Validation Engineer

The Validation Engineer will be reporting to the Validation Manager, the role will hold responsibilities for ensuring products are manufactured using equipment and facilities that comply with GMP requirements specified by the Company and Regulatory bodies.

Client Details

This is a great time for the Validation Engineer to join the company they are expanding their production next year to double capacity. The company have seen huge successes with their wide range of products.

Description

The Validation Engineer:

Main Responsibilities

Supporting the execution of the on site validation strategy in accordance with the Validation Master Plan, including through ongoing management of the Site Validation Programme.

Supporting the Validation Manager with writing and execution of retrospective equipment, facilities and utilities validation IQ, OQ and PQ activities, including re-validations, as required.

Generating, amending and implementing Standard Operating Procedures (SOPs) and Works Instructions and conducting of training thereafter to relevant staff as required.

Assisting with management of the Calibration programme, including with performance of internal calibration activities where necessary, to ensure equipment is calibrated on time and to an acceptable standard.

Participation in Internal and External Audit activities as required.

To take on additional responsibilities as the role progresses as deemed appropriate by the Validation Manager and the wider Quality Assurance Team, including participation in CSV and Cleaning Validation activities as well as other ongoing quality projects.

Profile

The ideal Validation Engineer will have a degree or equivalent in a Science or Engineering discipline and ideally experience working in a food, pharmaceutical or other relevant GMP regulated industry. Working knowledge of the Validation Life-cycle, including URS, DQ, IQ, OQ and PQ, and CSV and Cleaning Validation is desirable, but not essential.

Candidates must have an excellent level of attention to detail and ability to work with high level of accuracy and precision, along with high analytical skills and a creative approach to problem solving. Good interpersonal skills to build relations throughout the business are essential as are strong communication skills, particularly in the field of protocol and report writing. A high level of IT skills including Microsoft Word and Excel is essential.